Bioequivalence and Bioavailability Forum

Subject	Author	Posted	Rep.	last R.	Views
ICH M13A (IR BE) ICH M13A (IR BE) ICH M13A (IR BE) ICH M13A (IR BE) ICH M13A (IR BE) ICH M13A (IR BE) ICH M13A (IR BE) : FDA web site Knowledge is power… ICH M13A (IR BE): EMA consultation ICH M13A (IR BE): EMA comments received	Helmut	2022-12-23 09:05	9	2023-09-18 10:54	3,503
WHO Draft on BCS-based Biowaivers	Helmut	2023-08-29 11:18	0		765
EMA: New product-specific guidances How would you implement it? Confuse a Cat Inc. Confuse a Cat Inc. Confuse a Cat Inc. Confuse a Cat Inc. Range Range Range Range So many questions, so few answers Preliminary simulations Preliminary simulations Preliminary simulations Revisions of the PSGLs final Revisions of the PSGLs final EMA: No problems with many sampling time points… New simulations & some desultory thoughts SCNR. A heretic alternative. Simulated distributions	Helmut	2022-04-08 15:17	19	2023-06-30 11:50	5,202
ICH E6(R3) draft Guideline reaches Step 2 of the ICH process Validation of sample size estimations?	SMA	2023-05-24 08:37	1	2023-05-29 08:34	1,064
FDA draft guidance on transdermal systems	Ohlbe	2023-04-13 08:37	0		844
New guidance on Statistical Approaches to Establishing Bioequivalence A first look A first look A first look SAS strikes back SAS strikes back Outliers? Outliers? SAS strikes back model-based BE? model-based BE? Hooker, Moellenhoff et al. are moving MBBE forward model-based BE? A first look A first look Groups, sites… SxF SxF New guidance on Statistical Approaches to Establishing Bioequivalence Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence Webinar: A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence Multi-group studies ad nauseam Multi-group studies ad nauseam Webinar: Recording available Speed kills	Relaxation	2022-12-02 15:53	24	2023-04-01 10:38	5,409
EMA Methodology Working Party EMA Methodology Working Party	Helmut	2022-10-01 09:53	1	2022-11-08 10:09	2,060
ANVISA RDC Nº 742 ANVISA RDC Nº 749	Helmut	2022-09-12 10:27	1	2022-09-16 17:13	2,639
ICH M12 (DDI studies)	Helmut	2022-07-29 13:53	0		1,324
Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology	suchit_bhavsar	2022-06-29 07:37	0		1,052
Publication of the final ICH M10 guideline Publication of the final ICH M10 guideline Chromatograms	Ohlbe	2022-06-10 10:48	2	2022-06-14 09:37	2,049
New FDA bioavailability guidance New FDA bioavailability guidance New FDA bioavailability guidance Excellent post!	wienui	2022-04-15 09:44	3	2022-04-17 11:03	2,274
Bempedoic Acid TBM BE study in SBOA Bempedoic Acid TBM BE study in SBOA	dshah	2022-03-30 17:09	1	2022-03-31 06:43	1,627
Observational studies Observational studies … real-world evidence …	Helmut	2021-12-27 10:24	2	2022-02-11 09:38	2,273
EMA BE-GL: Clarifications / Corrections? Good news!? Good news!? Update Q&A published 14 March 2011 Q&A published 14 March 2011 Phoenix/WinNonlin 6.1.0.173 ANOVA party prevails THX! Outlier Outliers - yes, but how? Questions and Ambiguities Residuals and Outliers in Replicate Design Crossover Studies Info requested Confused as well... Q&A published 14 March 2011 SAS code: Warning Copy & paste Subtleties, flaws, questions Subtleties, flaws, questions Not estimable in the model Not estimable in the model Not estimable in the model Not estimable in the model Not estimable in the model Food not the same between groups Food not the same between groups	Helmut	2010-06-22 18:53	26	2021-11-17 08:50	37,552